Catalog Number

-

Brand Name

Tex-Care Medical

Version/Model Number

81161-648

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K955749

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

36d070c6-3d63-458f-a95e-c86c77a64bf8

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-